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Can a Real-World study reveal the staying power of guselkumab?

NCT ID NCT07746765

Disease control Sponsor: Janssen Sciences Ireland UC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This observational study tracks how long patients with moderate-to-severe Crohn's disease or ulcerative colitis continue taking guselkumab, a biologic treatment, in everyday clinical practice. Researchers will measure time until treatment discontinuation and early responses like bowel urgency. The goal is to understand real-world persistence and inform treatment decisions for inflammatory bowel disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guselkumab
What this could lead to
If successful, this study could reveal how long patients typically stay on guselkumab, helping doctors and patients make more informed treatment decisions for inflammatory bowel disease.
What could go wrong
This is a small observational study, so results may not apply broadly. It does not test new effects of the drug, and persistence may vary due to factors not fully captured.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or ulcerative colitis (UC) disease receiving guselkumab in routine clinical practice.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug * Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records * Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements Exclusion criteria: * Contraindicated to guselkumab per the label * Is currently enrolled in an interventional clinical study * Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included * History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules) * Is unable to provide informed consent

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colitis ulcerative Crohn disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.